FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy

FDA discusses key issues in reviewing first-in-human clinical protocols for cellular and gene therapy products for the treatment of cancer. FDA also shares pitfalls to avoid when describing these studies and lessons learned from successful oncology and gene therapy products.
Presenter:
Peter Bross, MD, Chief (Acting), Oncology Branch, Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissues and Advanced Therapies (OTAT), CBER
Learn more at: www.fda.gov/drugs/news-events...
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